Doxil Loss a Big Problem for Cancer Patients

Maurie Markman, MD


October 24, 2013

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Hello. I am Dr. Maurie Markman from Cancer Treatment Centers of America in Philadelphia, and I want to briefly discuss a recent announcement that is by now familiar to all oncologists: that pegylated liposomal doxorubicin (specifically the product Doxil®) will again not be available to oncologists to use in patients -- and in my practice, patients with ovarian cancer.

Pegylated liposomal doxorubicin has been shown in a number of clinical trials[1,2] to be well tolerated both when given alone and in combination with carboplatin. A recent report[3] has shown that in the platinum resistance setting, given with bevacizumab and other antineoplastic cytotoxic agents, Doxil can improve time to disease progression. The drug is a very important part of our armamentarium, and the lack of availability of Doxil is a concern. We have been assured by the US Food and Drug Administration that another product can take its place. That is helpful, but we remain concerned that we again have a shortage of this agent when we have been promised that the problem was going to be fixed. That clearly is not the case.

This event shows once again that we have a serious problem with the antineoplastic drug development strategy in this country, whether it is involving the regulatory agencies or how we prevent shortages of generic drugs that are very effective. This problem needs to be solved. It is not a problem for the oncologist. It is not a problem for the regulatory agencies. It is not a problem for the drug companies. It is a problem for our patients. We have effective drugs that we know are well tolerated, and these drugs are not available to give to our patients when we know they are beneficial. The reasons for the lack of availability do not make any sense whatsoever.

We have a problem that needs to be fixed, and I call upon all of those involved -- and particularly the regulatory agencies, and perhaps even Congress itself -- to look into this issue and examine it closely to figure out a solution, because this is not just an issue of a drug not being available. This is an issue of patients not being given the best possible care, and this is a problem we must solve.


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